Field Action Manager

Role: FIELD
ACTION MANAGER

Location: ZUCHWIL (SOLOTHURN) AT SYNTHES,
SWITZERLAND

Rate: Negotiable

Start Date: ASAP

Role Profile:

- Investigation on complaints that have been escalated to
become potential field actions

- Leads coordinates all the investigations to have
documentation ready to decide if there is a product recall

• Ensuring the appropriate communication of Field Actions
to the competent authorities

- Follow-up and closing statements about Field Actions to
the competent authorities

- Central point of contact for the RA in relevant
countries as well as internal agencies for assistance to FAs

- Knowledge and analysis of the local regulatory rules
and guidelines

- Documentation of all activities

- Communication with various authorities regarding FA's

- Communication with non-governmental agencies with
respect to FA's

- Monitoring of the TG's communication regarding the
authorities to FA's

- Insertion of a tool for monitoring / tracking of FA's

- Knowledge and experience of country-specific
requirements for mandatory reporting of FA's

- Coordination of communication to authorities with the
TG's

- Knowledge and execution of the guidelines on code of
conduct, ethics and compliance programs and other relevant regulations

Substitute to the FA Manager

Process Owner for "Field Actions" along with
the Post Market Risk Manager

REQUIREMENTS:

Higher Education in Engineering or related fields

3-5 yrs experience in Medical Device or related fields

Knowledge of regulatory environment is a definite plus

LANGUAGES:

English - must

German - desirable

High Degree of Emotional Intelligence - as you request
the work, get things done

Ability to dealing with high workloads and short
timelines

Perseverance, decision-making ability, communication
skills, conflict resolution skills, customer focus, planning ability,
assertiveness, team player